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HMT Inhibitor
Phase 2 Group 3: Tazemetostat in R/R DLBCL for B-Cell Lymphoma
Phase 1 & 2
Waitlist Available
Research Sponsored by Epizyme, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up radiologic tumor assessments performed at baseline (within 28 days before start of study treatment) and every 8 weeks during cycles 2 to 6, and then every 12 weeks thereafter until confirmed pd/death, a maximum of approximately 82 months
Awards & highlights
Summary
This is an open-label, multicenter, Phase 1/2 study of tazemetostat as a single agent in subjects with advanced solid tumors or with B-cell lymphomas and tazemetostat in combination with prednisolone in subjects with diffuse large B-cell lymphoma (DLBCL).
Eligible Conditions
- B-Cell Lymphoma
- Solid Tumors
- Diffuse Large B-Cell Lymphoma
- Follicular Lymphoma
- Large B-Cell Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ radiologic tumor assessments performed at baseline (within 28 days before start of study treatment) and every 8 weeks during cycles 2 to 6, and then every 12 weeks thereafter until confirmed pd/death, a maximum of approximately 82 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~radiologic tumor assessments performed at baseline (within 28 days before start of study treatment) and every 8 weeks during cycles 2 to 6, and then every 12 weeks thereafter until confirmed pd/death, a maximum of approximately 82 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR; Complete Response + Partial Response [CR + PR]) (Phase 2)
Recommended Phase 2 Dose (RP2D) of Tazemetostat as a Single-Agent and in Combination With Prednisolone (Phase 1 Only)
Secondary outcome measures
Duration of Response for Tazemetostat as a Single Agent or in Combination With Prednisolone (Phase 2 Only)
Progression Free Survival for Tazemetostat as a Single Agent or in Combination With Prednisolone (Phase 2 Only)
Trial Design
4Treatment groups
Experimental Treatment
Group I: Phase 2 Group 3: Tazemetostat in R/R DLBCLExperimental Treatment2 Interventions
Patients with R/R DLBCL treated with tazemetostat as a single agent or tazemetostat in combination with prednisolone in Phase 2 of the study.
Group II: Phase 2 Group 2: Tazemetostat in R/R FL with Wild-Type EZH2Experimental Treatment1 Intervention
Patients with R/R FL with wild-type EZH2 treated with tazemetostat as a single agent in Phase 2 of the study.
Group III: Phase 2 Group 1: Tazemetostat in R/R FL with Mutant EZH2Experimental Treatment1 Intervention
Patients with R/R FL with mutant EZH2 treated with tazemetostat as a single agent in Phase 2 of the study.
Group IV: Phase 1Experimental Treatment1 Intervention
Patients in the Phase 1 portion of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazemetostat
2016
Completed Phase 2
~1050
Prednisolone
2005
Completed Phase 4
~2720
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Who is running the clinical trial?
Epizyme, Inc.Lead Sponsor
33 Previous Clinical Trials
2,523 Total Patients Enrolled
Ipsen Medical DirectorStudy DirectorIpsen
259 Previous Clinical Trials
55,401 Total Patients Enrolled
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